Actively Recruiting
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
Led by Merck Sharp & Dohme LLC · Updated on 2026-03-05
58
Participants Needed
3
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tolerate it.
CONDITIONS
Official Title
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 18.0 and 42.0 kg/m2
- Diagnosis of chronic, stable hepatic insufficiency with cirrhosis for hepatic impairment participants
- Medically healthy with no clinically significant medical history for healthy volunteers
You will not qualify if you...
- History of gastrointestinal disease affecting food or drug absorption
- History of cancer (malignancy)
- Positive test for HIV
- Major surgery or significant blood loss within 56 days prior to dosing
- Severe liver disease complications within 3 months before screening (hepatic impairment participants)
- Recent variceal bleeds within 3 months prior to screening (hepatic impairment participants)
- Evidence of hepatorenal syndrome (hepatic impairment participants)
- Anticipated survival less than 3 months due to unstable hepatic impairment
- History of liver or other solid organ transplant
- Active infection needing systemic therapy
- More than 2 paracentesis procedures per month
- Presence of transjugular intrahepatic portosystemic shunt or portacaval shunting
- Use of antiviral or immune therapies for hepatitis B or C within 90 days before dosing
- Use of HIV protease inhibitors
- Positive for Hepatitis B surface antigen or Hepatitis C virus
- Positive Hepatitis B or C tests for healthy volunteers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Arizona Clinical Trials ( Site 0003)
Chandler, Arizona, United States, 85225
Actively Recruiting
2
Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, United States, 32809
Actively Recruiting
3
The Texas Liver Institute ( Site 0002)
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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